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FDA 510(k)

Access Cortisol; DxC 500i Clinical Analyzer

K-Number: K242190 · 2025-03-05

ApplicantBeckman Coulter, Inc.
Decision Date2025-03-05
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access Cortisol; DxC 500i Clinical Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-03-05 under 510(k) number K242190. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Cortisol; DxC 500i Clinical Analyzer?

Access Cortisol; DxC 500i Clinical Analyzer is a medical device that received FDA 510(k) clearance on 2025-03-05. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K242190.

When did Access Cortisol; DxC 500i Clinical Analyzer receive FDA 510(k) clearance?

Access Cortisol; DxC 500i Clinical Analyzer received FDA 510(k) clearance on 2025-03-05, under 510(k) number K242190.

Who is the listed applicant for Access Cortisol; DxC 500i Clinical Analyzer?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Access Cortisol; DxC 500i Clinical Analyzer?

The FDA product code for Access Cortisol; DxC 500i Clinical Analyzer is CGR.

Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: CGR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223038Access CortisolBeckman Coulter, Inc.K202136IDS CortisolImmunodiagnostic Systems , Ltd.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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